Publications by authors named "Pierre Tiberghien"

149 Publications

An international comparison of HIV prevalence and incidence in blood donors and general population: a BEST Collaborative study.

Vox Sang 2021 Apr 9. Epub 2021 Apr 9.

Établissement Français du Sang, La Plaine Saint-Denis, France.

Background And Objectives: Efficiency in mitigating HIV transmission risk by transfusion may vary internationally. We compared HIV prevalence and incidence in blood donors across different jurisdictions in relation to those rates in the general population and differences in deferral practices.

Materials And Methods: Data from 2007 to 2016 were collected in Australia, Brazil (São Paulo), Canada, England, France, Italy, Ireland, Japan, the Netherlands, New Zealand, Norway, Spain (Basque Country), USA (Vitalant) and Wales. For each country/region, the number of HIV antibody-positive donations and nucleic acid testing (NAT)-only-positive donations was broken down according to first-time or repeat donor status, along with the relevant denominators.

Results: There is a modest correlation between HIV prevalence among first-time donors and HIV prevalence in the general population. However, rates of HIV-positive donations in repeat donors, a proxy for incidence, do not correlate with incidence rates in the general population. Rates in donors from Italy and Basque Country, where deferral criteria for men having sex with men are less stringent, are higher compared with most other jurisdictions. Rates of NAT-only-positive donations are extremely low and do not differ significantly after adjustment for multiple comparisons.

Conclusion: Donor HIV rates are only weakly associated with those observed in the general population. Countries with less stringent deferral criteria have higher HIV rates in their donor population, but the rates remain very low.
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http://dx.doi.org/10.1111/vox.13107DOI Listing
April 2021

Preventing transfusion-transmitted malaria in France.

Vox Sang 2021 Mar 27. Epub 2021 Mar 27.

Etablissement Français du Sang, La Plaine St-Denis, France.

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http://dx.doi.org/10.1111/vox.13097DOI Listing
March 2021

Lessons learned in the collection of convalescent plasma during the COVID-19 pandemic.

Vox Sang 2021 Mar 27. Epub 2021 Mar 27.

Unit Transfusion Medicine, Sanquin Blood Supply Foundation, Amsterdam, Netherlands.

Background: The lack of definitive treatment or preventative options for COVID-19 led many clinicians early on to consider convalescent plasma (CCP) as potentially therapeutic. Regulators, blood centres and hospitals worldwide worked quickly to get CCP to the bedside. Although response was admirable, several areas have been identified to help improve future pandemic management.

Materials And Methods: A multidisciplinary, multinational subgroup from the ISBT Working Group on COVID-19 was tasked with drafting a manuscript that describes the lessons learned pertaining to procurement and administration of CCP, derived from a comprehensive questionnaire within the subgroup.

Results: While each country's responses and preparedness for the pandemic varied, there were shared challenges, spanning supply chain disruptions, staffing, impact of social distancing on the collection of regular blood and CCP products, and the availability of screening and confirmatory SARS-CoV-2 testing for donors and patients. The lack of a general framework to organize data gathering across clinical trials and the desire to provide a potentially life-saving therapeutic through compassionate use hampered the collection of much-needed safety and outcome data worldwide. Communication across all stakeholders was identified as being central to reducing confusion.

Conclusion: The need for flexibility and adaptability remains paramount when dealing with a pandemic. As the world approaches the first anniversary of the COVID-19 pandemic with rising rates worldwide and over 115 million cases and 2·55 million deaths, respectively, it is important to reflect on how to better prepare for future pandemics as we continue to combat the current one.
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http://dx.doi.org/10.1111/vox.13096DOI Listing
March 2021

HIV transmission network analysis allows identifying unreported risk factors in HIV-positive blood donors in France.

Transfusion 2021 Apr 16;61(4):1191-1201. Epub 2021 Feb 16.

Département des Agents Transmissibles par le Sang, CNR Risques Infectieux Transfusionnels, Institut National de la Transfusion Sanguine (INTS), Paris, France.

Objectives: As sex between men is a major route of human immunodeficiency virus (HIV) infection in most western countries, restrictive deferral rules for blood donation have largely been implemented regarding men having sex with men (MSM). Here, we sought here to assign unreported HIV risk factors in blood donors (BDs) and reevaluated the MSM-associated fraction of HIV transfusion residual risk (%RR ).

Methods: We applied a genetic distance-based approach to infer an HIV transmission network for 384 HIV sequences from French BDs and 1337 HIV sequences from individuals with known risk factors (ANRS PRIMO primary HIV infection cohort). We validated the possibility of assigning a risk factor according to clustering using assortative mixing. Finally, we recalculated the %RR .

Results: A total of 81 of 284 (28.5%) male and 5 of 100 (5%) female BDs belonged to a cluster; 72 (88.9%) of the 81 male BDs belonged to MSM clusters. After cluster correction, 8 of 67 (11.9%), 4 of 21 (19.0%), and 19 of 88 (21.6%) HIV-positive (HIV+) male BDs with heterosexual, other, or unknown risk factors could be reclassified as MSM, accounting for 10.9% of the total HIV+ male BDs. Overall, 139 of 284 HIV+ male donors (48.9%) could be considered MSM between 2000 and 2016 in France. Between 2005 and 2016, the %RR increase varied from 0 to 19%, without differing significantly from the %RR before reclassification.

Conclusion: Network inference can be used to complement declaration data on risk factors for HIV infection in BDs. This approach, complementary to behavioral studies, is a valuable tool to evaluate the effect of changes in deferral criteria on BD compliance.
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http://dx.doi.org/10.1111/trf.16290DOI Listing
April 2021

A look-back at convalescent plasma to treat COVID-19.

Transfus Apher Sci 2021 02 12;60(1):103063. Epub 2021 Jan 12.

Etablissement Français du Sang, La Plaine, St Denis, France; UMR RIGHT 1098, Inserm, Etablissement Français du Sang, Université de Franche-Comté, Besançon, France.

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http://dx.doi.org/10.1016/j.transci.2021.103063DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7802586PMC
February 2021

Evaluation of SARS-CoV-2 antibody titers and potency for convalescent plasma donation: a brief commentary.

Vox Sang 2020 Dec 23. Epub 2020 Dec 23.

Department of Immunopathology, Sanquin Research and Landsteiner Laboratory Academic Medical Centre, Amsterdam, Netherlands.

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http://dx.doi.org/10.1111/vox.13060DOI Listing
December 2020

Risk for Hepatitis E Virus Transmission by Solvent/Detergent-Treated Plasma.

Emerg Infect Dis 2020 12;26(12):2881-2886

Hepatitis E has emerged as a major transfusion-transmitted infectious risk. Two recipients of plasma from 2 lots (A and B) of pooled solvent/detergent-treated plasma were found to be infected by hepatitis E virus (HEV) that was determined to have been transmitted by the solvent/detergent-treated plasma. HEV RNA viral loads were 433 IU in lot A and 55 IU in lot B. Retrospective studies found that 100% (13/13) of evaluable lot A recipients versus 18% (3/17) of evaluable lot B recipients had been infected by HEV (p<0.001), albeit not necessarily at time of transfusion. Among evaluable recipients, 86% with a transfused HEV RNA load >50,000 IU were infected, most likely by the HEV-containing solvent/detergent-treated plasma, versus only 7% with a transfused HEV RNA load <50,000 IU (p<0.001). Overall, solvent/detergent-treated plasma might harbor HEV. Such an occurrence might result in a dose-dependent risk for transfusion-transmitted hepatitis E.
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http://dx.doi.org/10.3201/eid2612.191482DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7706953PMC
December 2020

Processing methods and storage duration impact extracellular vesicle counts in red blood cell units.

Blood Adv 2020 11;4(21):5527-5539

University Bourgogne Franche-Comté, INSERM, Etablissement Français du sang Bourgogne Franche Comté, Unité Mixte de Recherche 1098, Interactions Hôte-Greffon-Tumeur, Ingénierie Cellulaire et Génique, Besançon, France.

Extracellular vesicles (EVs) are active components of red blood cell (RBC) concentrates and may be associated with beneficial and adverse effects of transfusion. Elucidating controllable factors associated with EV release in RBC products is thus important to better manage the quality and properties of RBC units. Erythrocyte-derived EVs (EEVs) and platelet-derived EVs (PEVs) were counted in 1226 RBC units (administered to 280 patients) using a standardized cytometry-based method. EV size and CD47 and annexin V expression were also measured. The effects of donor characteristics, processing methods, and storage duration on EV counts were analyzed by using standard comparison tests, and analysis of covariance was used to determine factors independently associated with EV counts. PEV as well as EEV counts were higher in whole-blood-filtered RBC units compared with RBC-filtered units; PEV counts were associated with filter type (higher with filters associated with higher residual platelets), and CD47 expression was higher on EEVs in RBC units stored longer. Multivariate analysis showed that EEV counts were strongly associated with filter type (P < .0001), preparation, and storage time (+25.4 EEV/µL per day [P = .01] and +42.4 EEV/µL per day [P < .0001], respectively). The only independent factor associated with PEV counts was the residual platelet count in the unit (+67.1 PEV/µL; P < .0001). Overall, processing methods have an impact on EV counts and characteristics, leading to large variations in EV quantities transfused into patients. RBC unit processing methods might be standardized to control the EV content of RBC units if any impacts on patient outcomes can be confirmed. The IMIB (Impact of Microparticles in Blood) study is ancillary to the French ABLE (Age of Transfused Blood in Critically Ill Adults) trial (ISRCTN44878718).
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http://dx.doi.org/10.1182/bloodadvances.2020001658DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7656935PMC
November 2020

Remdesivir failure with SARS-CoV-2 RNA-dependent RNA-polymerase mutation in a B-cell immunodeficient patient with protracted Covid-19.

Clin Infect Dis 2020 Sep 28. Epub 2020 Sep 28.

Sorbonne Université, Inserm IPLESP, Infectious Diseases Department, Saint-Antoine Hospital, APHP, Paris - France.

SARS-CoV-2 is a new pandemic virus for which Remdesivir is the only antiviral available. We report the occurrence of a mutation in the RdRP (D484Y) following failure of remdesivir in a 76-year-old woman with a post-rituximab B-cell immunodeficiency and persistent SARS-CoV-2 viremia. Cure was reached after supplementation with convalescent plasma.
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http://dx.doi.org/10.1093/cid/ciaa1474DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7543308PMC
September 2020

Convalescent plasma therapy for B-cell-depleted patients with protracted COVID-19.

Blood 2020 11;136(20):2290-2295

Infectious Diseases Department, Saint-Antoine Hospital, AP-HP, Paris, France.

Anti-CD20 monoclonal antibodies are widely used for the treatment of hematological malignancies or autoimmune disease but may be responsible for a secondary humoral deficiency. In the context of COVID-19 infection, this may prevent the elicitation of a specific SARS-CoV-2 antibody response. We report a series of 17 consecutive patients with profound B-cell lymphopenia and prolonged COVID-19 symptoms, negative immunoglobulin G (IgG)-IgM SARS-CoV-2 serology, and positive RNAemia measured by digital polymerase chain reaction who were treated with 4 units of COVID-19 convalescent plasma. Within 48 hours of transfusion, all but 1 patient experienced an improvement of clinical symptoms. The inflammatory syndrome abated within a week. Only 1 patient who needed mechanical ventilation for severe COVID-19 disease died of bacterial pneumonia. SARS-CoV-2 RNAemia decreased to below the sensitivity threshold in all 9 evaluated patients. In 3 patients, virus-specific T-cell responses were analyzed using T-cell enzyme-linked immunospot assay before convalescent plasma transfusion. All showed a maintained SARS-CoV-2 T-cell response and poor cross-response to other coronaviruses. No adverse event was reported. Convalescent plasma with anti-SARS-CoV-2 antibodies appears to be a very promising approach in the context of protracted COVID-19 symptoms in patients unable to mount a specific humoral response to SARS-CoV-2.
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http://dx.doi.org/10.1182/blood.2020008423DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7702482PMC
November 2020

Potential human transmission of amyloid β pathology: surveillance and risks.

Lancet Neurol 2020 10 16;19(10):872-878. Epub 2020 Sep 16.

VIB-KU Leuven Center for Brain and Disease Research, KU Leuven, Leuven, Belgium; Department of Neurosciences, Leuven Brain Institute, KU Leuven, Leuven, Belgium; UK Dementia Research Institute, University College London, London, UK. Electronic address:

Studies in experimental animals show transmissibility of amyloidogenic proteins associated with prion diseases, Alzheimer's disease, Parkinson's disease, and other neurodegenerative diseases. Although these data raise potential concerns for public health, convincing evidence for human iatrogenic transmission only exists for prions and amyloid β after systemic injections of contaminated growth hormone extracts or dura mater grafts derived from cadavers. Even though these procedures are now obsolete, some reports raise the possibility of iatrogenic transmission of amyloid β through putatively contaminated neurosurgical equipment. Iatrogenic transmission of amyloid β might lead to amyloid deposition in the brain parenchyma and blood vessel walls, potentially resulting in cerebral amyloid angiopathy after several decades. Cerebral amyloid angiopathy can cause life-threatening brain haemorrhages; yet, there is no proof that the transmission of amyloid β can also lead to Alzheimer's dementia. Large, long-term epidemiological studies and sensitive, cost-efficient tools to detect amyloid are needed to better understand any potential routes of amyloid β transmission and to clarify whether other similar proteopathic seeds, such as tau or α-synuclein, can also be transferred iatrogenically.
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http://dx.doi.org/10.1016/S1474-4422(20)30238-6DOI Listing
October 2020

Platelet transfusions in haematologic malignancies in the last six months of life.

Vox Sang 2021 Apr 13;116(4):425-433. Epub 2020 Aug 13.

EFS Bourgogne Franche Comté, Besançon, France.

Background And Objectives: Practices in end-of-life platelet transfusions in haematologic malignancies are variable. Our aim was to describe the platelet transfusion burden and parameters linked to this indication in such a setting and thereby contribute to defining optimal practices.

Materials And Methods: From July 2015 to December 2016, all consecutive deceased adult patients with a haematologic malignancy receiving a platelet transfusion in the last 6 months of their life from the Etablissement Français du Sang Bourgogne Franche-Comté were included retrospectively. The outcome criteria were changes in the number of platelet transfusions, percent platelet recovery, platelet transfusion interval, reported bleeding with its grade and recipient adverse events in the last 6 months of life.

Results: Among the 1125 patients monitored, 119 were included in our study. Bleeding prophylaxis (versus treatment) was the reason for 55% of transfusions. 18% of platelet concentrates (n = 1999) were transfused during the last two weeks of life. As death approached, the transfusion and haemorrhage burden increased (P < 0·0001 in both cases), whereas platelet recovery and transfusion interval decreased (P = 0·02 in both cases). Recipient adverse events were rare (0·6%) and of minor severity.

Conclusion: In end-of-life transfused patients with haematologic malignancies, approaching death is associated with an increased number of platelet transfusions and bleeding events, while platelet recovery and transfusion intervals are reduced. Such findings, together with further evaluations, may contribute to informing best practices for these patients.
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http://dx.doi.org/10.1111/vox.12986DOI Listing
April 2021

Guidance for the procurement of COVID-19 convalescent plasma: differences between high- and low-middle-income countries.

Vox Sang 2021 Jan 20;116(1):18-35. Epub 2020 Jul 20.

Department Unit Transfusion Medicine, Sanquin Blood Supply Foundation, Amsterdam, NL, Netherlands.

Background And Objectives: COVID-19 convalescent plasma (CCP) has been used, predominantly in high-income countries (HICs) to treat COVID-19; available data suggest the safety and efficacy of use. We sought to develop guidance for procurement and use of CCP, particularly in low- and middle-income countries (LMICs) for which data are lacking.

Materials And Methods: A multidisciplinary, geographically representative group of individuals with expertise spanning transfusion medicine, infectious diseases and haematology was tasked with the development of a guidance document for CCP, drawing on expert opinion, survey of group members and review of available evidence. Three subgroups (i.e. donor, product and patient) were established based on self-identified expertise and interest. Here, the donor and product-related challenges are summarized and contrasted between HICs and LMICs with a view to guide related practices.

Results: The challenges to advance CCP therapy are different between HICs and LMICs. Early challenges in HICs related to recruitment and qualification of sufficient donors to meet the growing demand. Antibody testing also posed a specific obstacle given lack of standardization, variable performance of the assays in use and uncertain interpretation of results. In LMICs, an extant transfusion deficit, suboptimal models of donor recruitment (e.g. reliance on replacement and paid donors), limited laboratory capacity for pre-donation qualification and operational considerations could impede wide adoption.

Conclusion: There has been wide-scale adoption of CCP in many HICs, which could increase if clinical trials show efficacy of use. By contrast, LMICs, having received little attention, require locally applicable strategies for adoption of CCP.
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http://dx.doi.org/10.1111/vox.12970DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7323328PMC
January 2021

Trends in platelet distributions from 2008 to 2017: a survey of twelve national and regional blood collectors.

Vox Sang 2020 Nov 13;115(8):703-711. Epub 2020 Apr 13.

Vitalant, Pittsburgh, PA, USA.

Background: This multi-national study evaluated changes in platelet (PLT) unit distributions at 12 national or regional blood collectors over a 10-year period.

Methods: Data on the total number of PLT distributions, the collection method, that is apheresis vs whole blood-derived (WBD), the PLT unit characteristics and post-collection modifications were obtained from 12 national or regional blood collectors from 2008 through 2017. Individual WBD PLT units were converted to apheresis equivalent units (i.e. a dose of PLTs) by dividing by 4, the typical pool size; WBD units that were pooled before distribution were counted as a single dose.

Results: Overall at these 12 blood collectors, the total number of PLTs distributed in 2008 was 1 373 200, which rose by 10·2% to 1 513 803 in 2017. The Japanese Red Cross, which distributes only apheresis PLTs, had a 13·4% increase in the number of distributions between the years 2008 and 2017, while the other 11 blood collectors combined demonstrated a 6·8% increase in distributions between these two years. Between the years 2008 and 2017, the changes in the proportion of apheresis, platelet-rich plasma and buffy coat PLT distributions were -29·9%, -70·7% and 80·0%, respectively.

Conclusion: The number of PLT distributions increased during the 10-year study period despite prophylactic PLT transfusion thresholds having remained fairly consistent over the last decade. Perhaps this increase is in part driven by increased administration of platelets to patients with massive haemorrhage or an increase in stem cell transplantation. The use of buffy coat PLTs is increasing at these collectors.
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http://dx.doi.org/10.1111/vox.12917DOI Listing
November 2020

Collecting and evaluating convalescent plasma for COVID-19 treatment: why and how?

Vox Sang 2020 Aug 3;115(6):488-494. Epub 2020 May 3.

REACTing Inserm, Paris, France.

Plasma provided by COVID-19 convalescent patients may provide therapeutic relief as the number of COVID-19 cases escalates steeply worldwide. Prior findings in various viral respiratory diseases including SARS-CoV-related pneumonia suggest that convalescent plasma can reduce mortality, although formal proof of efficacy is still lacking. By reducing viral spread early on, such an approach may possibly downplay subsequent immunopathology. Identifying, collecting, qualifying and preparing plasma from convalescent patients with adequate SARS-CoV-2-neutralizing Ab titres in an acute crisis setting may be challenging, although well within the remit of most blood establishments. Careful clinical evaluation should allow to quickly establish whether such passive immunotherapy, administered at early phases of the disease in patients at high risk of deleterious evolution, may reduce the frequency of patient deterioration, and thereby COVID-19 mortality.
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http://dx.doi.org/10.1111/vox.12926DOI Listing
August 2020

Donor-targeted serotherapy as a rescue therapy for steroid-resistant acute GVHD after HLA-mismatched kidney transplantation.

Am J Transplant 2020 08 10;20(8):2243-2253. Epub 2020 Mar 10.

Paris University, Paris, France.

Acute graft-versus-host disease (GVHD) is a rare but frequently lethal complication after solid organ transplantation. GVHD occurs in unduly immunocompromised hosts but requires the escalation of immunosuppression, which does not discriminate between host and donor cells. In contrast, donor-targeted therapy would ideally mitigate graft-versus-host reactivity while sparing recipient immune functions. We report two children with end-stage renal disease and severe primary immune deficiency (Schimke syndrome) who developed severe steroid-resistant acute GVHD along with full and sustained donor T cell chimerism after isolated kidney transplantation. Facing a therapeutic dead end, we used a novel strategy based on the adoptive transfer of anti-HLA donor-specific antibodies (DSAs) through the transfusion of highly selected plasma. After approval by the appropriate regulatory authority, an urgent nationwide search was launched among more than 3800 registered blood donors with known anti-HLA sensitization. Adoptively transferred DSAs bound to and selectively depleted circulating donor T cells. The administration of DSA-rich plasma was well tolerated and notably did not induce antibody-mediated rejection of the renal allografts. Acute GVHD symptoms promptly resolved in one child. This report provides a proof of concept for a highly targeted novel therapeutic approach for solid organ transplantation-associated GVHD.
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http://dx.doi.org/10.1111/ajt.15827DOI Listing
August 2020

Variations in hemoglobin measurement and eligibility criteria across blood donation services are associated with differing low-hemoglobin deferral rates: a BEST Collaborative study.

Transfusion 2020 03 8;60(3):544-552. Epub 2020 Feb 8.

Donor Studies, Department of Donor Medicine Research, Sanquin Research, Amsterdam, The Netherlands.

Background: Determination of blood donor hemoglobin (Hb) levels is a pre-requisite to ensure donor safety and blood product quality. We aimed to identify Hb measurement practices across blood donation services and to what extent differences associate with low-Hb deferral rates.

Methods: An online survey was performed among Biomedical Excellence for Safer Transfusion (BEST) Collaborative members, extended with published data. Multivariable negative-binomial regression models were built to estimate adjusted associations of minimum donation intervals, Hb cut-offs (high, ≥13.5 g/dL in men or ≥ 12.5 g/dL in women, vs. lower values), iron monitoring (yes/no), providing or prescribing iron supplementation (yes/no), post-versus pre-donation Hb measurement and geographical location (Asian vs. rest), with low-Hb deferral rates.

Results: Data were included from 38 blood services. Low-Hb deferral rates varied from 0.11% to 8.81% among men and 0.84% to 31.85% among women. Services with longer minimum donation intervals had significantly lower deferral rates among both women (rate ratio, RR 0.53, 95%CI 0.33-0.84) and men (RR 0.53, 95%CI 0.31-0.90). In women, iron supplementation was associated with lower Hb deferral rates (RR 0.47, 95%CI 0.23-0.94). Finally, being located in Asia was associated with higher low-Hb deferral rates; RR 9.10 (95%CI 3.89-21.27) for women and 6.76 (95%CI 2.45-18.68) for men.

Conclusion: Differences in Hb measurement and eligibility criteria, particularly longer donation intervals and iron supplementation in women, are associated with variations in low-Hb deferral rates. These insights could help improve both blood donation service efficiency and donor care.
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http://dx.doi.org/10.1111/trf.15676DOI Listing
March 2020

The evolving blood donor deferral policy for men who have sex with men: impact on the risk of HIV transmission by transfusion in France.

Transfusion 2020 03 6;60(3):525-534. Epub 2020 Feb 6.

Santé publique France, Direction des Maladies Infectieuses, Saint-Maurice, France.

Background: Blood donation deferral for men who have sex with men (MSM) in France was reduced from permanent to 12 months in July 2016. To inform a further reduction of the deferral period, an HIV risk assessment was conducted with two scenarios: S1, 4-month deferral; S2, 4-month deferral only in the case of more than one sexual partner (i.e., similar to other blood donors).

Methods: Baseline HIV residual risk (RR) was calculated from July 2016 to December 2017, using the Incidence Rate-Window Period method. The impact of both scenarios on RR was assessed using data from surveys on MSM and blood donors, to estimate 1) the number of additional MSM expected to donate in each scenario and 2) HIV incidence among these donors.

Results: Baseline HIV RR was estimated at 1 in 6,380,000 donations. For S1, an additional 733 MSM donors, and an additional 0.09 HIV-positive donations were estimated, yielding an unchanged RR of 1 in 6,300,000. For S2, these numbers were estimated at 3102 and 3.92, respectively, yielding an RR of 1 in 4,300,000. Sensitivity analyses showed that, under worst-case assumptions, the RR would equal 1 in 6,225,000 donations for S1 and 1 in 3,000,000 for S2.

Conclusion: For both scenarios, the HIV RR remains very low. For S1, the risk is identical to the baseline RR. For S2, it is 1.5 times higher, and sensitivity analysis shows that this estimate is less robust than for S1. The French Minister of Health announced that S1 will be implemented in April 2020.
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http://dx.doi.org/10.1111/trf.15677DOI Listing
March 2020

The systematic use of evidence-based methodologies and technologies enhances shared decision-making in the 2018 International Consensus Conference on Patient Blood Management.

Vox Sang 2020 Jan 10;115(1):60-71. Epub 2019 Nov 10.

European Blood Alliance (EBA), Amsterdam, The Netherlands.

Background And Objectives: Patient Blood Management (PBM) aims to optimize the care of patients who might need a blood transfusion. The International Consensus Conference on PBM (ICC-PBM) aimed to develop evidence-based recommendations on three topics: preoperative anaemia, red blood cell transfusion thresholds and implementation of PBM programmes. This paper reports how evidence-based methodologies and technologies were used to enhance shared decision-making in formulating recommendations during the ICC-PBM.

Materials & Methods: Systematic reviews on 17 PICO (Population, Intervention, Comparison, Outcomes) questions were conducted by a Scientific Committee (22 international topic experts and one methodologist) according to GRADE (Grades of Recommendation, Assessment, Development and Evaluation) methodology. Evidence-based recommendations were formulated using Consensus Development Conference methodology.

Results: We screened 17 607 references and included 145 studies. The overall certainty in the evidence of effect estimates was generally low or very low. During the ICC, plenary sessions (100-200 stakeholders from a range of clinical disciplines and community representatives) were followed by closed sessions where multidisciplinary decision-making panels (>50 experts and patient organizations) formulated recommendations. Two chairs (content-expert and methodologist) moderated each session and two rapporteurs documented the discussions. The Evidence-to-Decision template (GRADEpro software) was used as the central basis in the process of formulating recommendations.

Conclusion: This ICC-PBM resulted in 10 clinical and 12 research recommendations supported by an international stakeholder group of experts in blood transfusion. Systematic, rigorous and transparent evidence-based methodology in a formal consensus format should be the new standard to evaluate (cost-) effectiveness of medical treatments, such as blood transfusion.
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http://dx.doi.org/10.1111/vox.12852DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7004058PMC
January 2020

Transfusion-Transmitted Hepatitis E Virus Infection in France.

Transfus Med Rev 2019 07 20;33(3):146-153. Epub 2019 Jun 20.

Etablissement Français du Sang, La Plaine St Denis, France; UMR 1098 Inserm, Etablissement Français du Sang, Université de Franche-Comté, Besançon, France. Electronic address:

There is growing concern regarding the risk of transfusion- transmitted (TT) hepatitis E. Since the first described case in 2006, several TT hepatitis E have been reported to the French hemovigilance network. We performed a retrospective analysis of all cases of TT hepatitis E reported between 2006 and 2016. Transfusion-transmitted hepatitis E with high imputability according to phylogenetic analysis occurred in 23 patients aged 8 to 88 years and involved mostly solid organ recipients (n = 9) or patients with malignant hematological diseases (n = 9, including 4 hematopoietic allograft recipients). Involved blood products were plasma (n = 7), among which 6 had undergone pathogen reduction with solvent/detergent (n = 4) or amotosalen + ultra-violet A (UVA) (n = 2 from 1 donation) treatments, red blood concentrates (n = 7), apheresis platelets concentrates (n = 3) and whole blood pooled platelets concentrates (n = 6), among which one had underwent amotosalen + UVA treatment. Median hepatitis E virus (HEV) RNA dose infused was 5.79 [4.36-10.10] log IU. HEV infection progressed to chronic hepatitis E in 14 (61%) immunocompromised patients, 2 of whom had advanced liver fibrosis at diagnosis. Chronic hepatitis E patients cleared HEV with ribavirin treatment (n = 10), after immunosuppressive drug reduction (n = 3), or spontaneously (n = 1). One additional organ transplant recipient with associated co-morbidities died with ongoing HEV infection and multiple organ failure. The other 8 (34.8%) patients with TT hepatitis E cleared HEV within 6 months with ribavirin treatment (n = 3), reduced immunosuppression (n = 1) or spontaneously (n = 4). Red cells, platelets, and plasma transfusions may be associated with TT hepatitis E that can evolve to chronic hepatitis E in immunocompromised patients. Hepatitis E virus has emerged in France as a clinically significant TT infection risk.
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http://dx.doi.org/10.1016/j.tmrv.2019.06.001DOI Listing
July 2019

The best blood product and its best use for each patient: An evolving role for hemovigilance?

Transfus Clin Biol 2019 Sep 15;26(3):188-191. Epub 2019 May 15.

Établissement français du sang, 93218 La-Plaine-Saint-Denis, France; Université de Franche-Comté, Établissement français du sang et Inserm, UMR 1098,, 25020, Besançon, France. Electronic address:

Transfusion efficacy is an important clinical outcome strongly contributing to transfusion safety. Optimal transfusion care will soon require taking into account novel criteria's in relation with donor, blood product and/or recipient characteristics. Hemovigilance may prepare for these evolutions.
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http://dx.doi.org/10.1016/j.tracli.2019.04.001DOI Listing
September 2019

Viral load and clinical manifestations of hepatitis E virus genotype 3 infections.

J Viral Hepat 2019 09 10;26(9):1139-1142. Epub 2019 Jun 10.

Laboratoire de Virologie, CHU Purpan, Toulouse, France.

A fraction of plasma donations undergoes hepatitis E virus (HEV) RNA screening since late 2014 in France. The aim of this study was to determine the frequency of HEV RNA as well as the viral load and the evolution of genotype distribution over a 3-year period (2015-2017) in asymptomatic blood donors in comparison with symptomatic patients routinely diagnosed. The overall detection rate of HEV RNA in plasma donations was 0.10% during the 3-year period, with a median viral load of 717 IU/mL (range: <60-168 000 IU/mL) in the 189 samples found HEV RNA positive. One hundred and twenty samples (64.4%) were successfully HEV genotyped. Most strains were HEV3f (n = 54; 44.3%) and HEV3c (n = 46; 37.7%). The genotype distribution was not different throughout the 3-year period and we found no association between the genotype and where the blood donors lived (P = 0.96). The HEV genotype distributions in infected blood donors and symptomatic patients were similar. However, the symptomatic patients had a higher viral load (median 282 000 IU/mL; range: <60-136 000 000 IU/mL; P < 0.01) than the blood donors. Overall, asymptomatic blood donors and patients with symptomatic hepatitis E had similar genotype distributions but the blood donors had lower viral loads.
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http://dx.doi.org/10.1111/jvh.13128DOI Listing
September 2019

Patient Blood Management: Recommendations From the 2018 Frankfurt Consensus Conference.

JAMA 2019 Mar;321(10):983-997

German Red Cross Blood Transfusion Service and Goethe University Clinics, Frankfurt/Main, Germany.

Importance: Blood transfusion is one of the most frequently used therapies worldwide and is associated with benefits, risks, and costs.

Objective: To develop a set of evidence-based recommendations for patient blood management (PBM) and for research.

Evidence Review: The scientific committee developed 17 Population/Intervention/Comparison/Outcome (PICO) questions for red blood cell (RBC) transfusion in adult patients in 3 areas: preoperative anemia (3 questions), RBC transfusion thresholds (11 questions), and implementation of PBM programs (3 questions). These questions guided the literature search in 4 biomedical databases (MEDLINE, EMBASE, Cochrane Library, Transfusion Evidence Library), searched from inception to January 2018. Meta-analyses were conducted with the GRADE (Grading of Recommendations, Assessment, Development, and Evaluation) methodology and the Evidence-to-Decision framework by 3 panels including clinical and scientific experts, nurses, patient representatives, and methodologists, to develop clinical recommendations during a consensus conference in Frankfurt/Main, Germany, in April 2018.

Findings: From 17 607 literature citations associated with the 17 PICO questions, 145 studies, including 63 randomized clinical trials with 23 143 patients and 82 observational studies with more than 4 million patients, were analyzed. For preoperative anemia, 4 clinical and 3 research recommendations were developed, including the strong recommendation to detect and manage anemia sufficiently early before major elective surgery. For RBC transfusion thresholds, 4 clinical and 6 research recommendations were developed, including 2 strong clinical recommendations for critically ill but clinically stable intensive care patients with or without septic shock (recommended threshold for RBC transfusion, hemoglobin concentration <7 g/dL) as well as for patients undergoing cardiac surgery (recommended threshold for RBC transfusion, hemoglobin concentration <7.5 g/dL). For implementation of PBM programs, 2 clinical and 3 research recommendations were developed, including recommendations to implement comprehensive PBM programs and to use electronic decision support systems (both conditional recommendations) to improve appropriate RBC utilization.

Conclusions And Relevance: The 2018 PBM International Consensus Conference defined the current status of the PBM evidence base for practice and research purposes and established 10 clinical recommendations and 12 research recommendations for preoperative anemia, RBC transfusion thresholds for adults, and implementation of PBM programs. The relative paucity of strong evidence to answer many of the PICO questions supports the need for additional research and an international consensus for accepted definitions and hemoglobin thresholds, as well as clinically meaningful end points for multicenter trials.
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http://dx.doi.org/10.1001/jama.2019.0554DOI Listing
March 2019

Transfusion of HIV-infected blood products despite highly sensitive nucleic acid testing.

Transfusion 2019 06 19;59(6):2046-2053. Epub 2019 Feb 19.

Département des Agents Transmissibles par le Sang, Centre National de Référence Risques Infectieux Transfusionnels, Institut National de la Transfusion Sanguine (INTS), Paris, France.

Background: In France, the risk of HIV transmission by transfusion was reduced by implementing pooled nucleic acid testing (NAT) in 2001 and individual NAT in 2010. We report here the first case in France of transfusion of human immunodeficiency virus (HIV)-infected blood donated during HIV pre-ramp-up phase that tested individual NAT negative.

Methods: Blood donations are screened for HIV antibodies and HIV RNA (ProcleixUltrio, Grifols; limit of detection at 95%, 23 copies/mL). When a repeat donor tests positive for HIV, a repository sample from the previous donation is tested with the Cobas Taqman HIV-1 test (CTM, Roche; limit of detection at 95%, 17 copies/mL).

Results: In August 2017, a 57-year-old male repeat donor was screened positive for HIV antibodies and RNA (plasma viral load, 11,599 copies/mL). The previous donation had tested negative with Ultrio in March 2017 but was positive with an unquantifiable plasma viral load when tested with CTM. Sequencing showed no mismatch between Ultrio primers/probes and the target sequence. HIV transmission was excluded by lookback studies in the recipient of platelets, which had been pathogen reduced, but not in the recipient of RBCs due to premature death.

Conclusion: This case demonstrates that the risk of contaminated donations due to the early HIV infection phase going undetected by highly sensitive NAT is real but exceptional. The absence of transmission to the platelets recipient could be due to the very low viral inoculum and/or to the efficacy of the viral inactivation. This case also highlights the additional value of a systematic donation archiving and the importance of donor education and predonation selection.
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http://dx.doi.org/10.1111/trf.15203DOI Listing
June 2019